This working occasion guideline was developed throughout a one-day assembly
The event of this steering was supported by an academic grant from Teva UK Ltd
The content material of the working occasion guideline and this text is impartial of and never influenced by the business sponsorship
ince Well being Service Round 180 was issued in 1998,1 the message has been that when there are two chlorofluorocarbon (CFC)-free variations of an inhaled drug, then the CFC-containing variant must be phased out with a view to meet the necessities of the Montreal Protocol.2 A second CFC-free beclometasone dipropionate (BDP) inhaler is lastly now out there, and with the supply of two CFC-free BDP gadgets, forecasts recommend that CFC-containing inhalers will most likely disappear by mid-2008. This projection is predicated on:
- CFC shares
- availability of elements for CFC-containing inhalers
- information that producers are discontinuing manufacturing of CFC-containing BDP gadgets.
Want for the rule
With lower than a yr through which to handle the change, a consensus guideline for all healthcare professionals concerned within the administration of sufferers with bronchial asthma was developed.3 Though the rule discusses the phasing out of all CFC-containing inhalers, it focuses primarily on gadgets containing BDP as these will quickly be unavailable.
The working occasion for creating the brand new guideline has laid out helpful info on the right way to handle the change, and it’s hoped this can stimulate a need in practices to plan forward and administer the switch successfully.3 The rule emphasises that this must be a managed course of, and highlights dosage equivalence as one thing healthcare professionals should think about when transferring sufferers to a brand new routine; the 2 CFC-free BDP merchandise usually are not each equal.
Impression on the apply
When switching a affected person from a CFC-containing inhaler to a different gadget, it’s also a perfect alternative to overview his or her bronchial asthma therapy. Nevertheless, as there’s nonetheless a while through which to impact the change, the method needn’t create a big extra workload and it must be potential to do the majority of the work alongside routine clinic exercise.
The Prescription Price Evaluation for England for 20064 signifies that over 4.2 million CFC-containing BDP inhalers had been allotted, which means that if every affected person used seven inhalers per yr, then over 600,000 sufferers in England can be affected by this transformation. These figures recommend that this can have a big workload affect on each apply in England.
There may additionally be monetary penalties arising from:3
- elevated administrative and workers prices of affected person opinions
- an increase in oblique prices if the affected person will not be provided enough help through the switch to the CFC-free inhaler, which may lead to a deterioration in bronchial asthma management and subsequent elevated prices of care.
These prices will be minimised by implementing a deliberate overview and switch to a brand new inhaler. Planning ought to bear in mind monetary, administrative, and scientific issues.
Managing the switch
The rule outlines methods that could be employed to handle the changeover. Changes to treatment must be effected with minimal disruption with a view to keep away from lack of bronchial asthma management and its consequent potential for adversarial results on sufferers and prices.3 The algorithm in Determine 1 incorporates a scheme for managing the change. The methods are mentioned beneath.
Determine 1: Managing the switch to CFC-free ICS inhalers for sufferers at present utilizing CFC-containing BDP gadgets
CFC=chlorofluorocarbon; ICS=inhaled corticosteroid; BDP=beclometasone dipropionate; pMDI= pressurised metered-dose inhaler; DPI=dry powder inhaler
Affected person overview
It’s preferable to see each affected person individually to debate the change in treatment, and this additionally offers a chance to verify his or her inhaler approach. By combining this with the annual overview, the extra workload related to the change will be minimised. Bronchial asthma management will be reviewed and any step up or down of the inhaled corticosteroid dose will be applied.
Computerised searches at practices can be utilized to establish sufferers due for overview and their notes will be flagged. If the affected person attends for one more purpose, there could also be a chance to overview their therapy and prescribe a CFC-free inhaler.
High quality and outcomes framework annual bronchial asthma opinions might current a chance to change if these are being carried out over the following few months. I like to recommend that practices estimate how a lot work is concerned and plan in response to their very own workload profiles.
A major variety of sufferers won’t attend for overview in any 12-month interval, and it might be acceptable to supply them particular person appointments or to debate the change over the telephone. It might be helpful to contemplate whether or not additional clinics should be provided throughout this changeover interval.
The consensus guideline additionally defines a listing of sufferers thought-about to be at excessive danger from a change of inhaler (see Field 1).3 These sufferers could also be focused for particular person appointments if a call is made to not see all sufferers.
Field 1: Bronchial asthma sufferers thought-about to be at excessive danger from an unsupervised
change in treatment
Sufferers thought-about to be at excessive danger are those that:
- use ?2 bronchodilator inhalers per 30 days
- have acquired a course of oral corticosteroids within the earlier 12 months
- don’t attend routine bronchial asthma opinions
- have been hospitalised or who’ve required out of hours bronchial asthma care over the previous 2 years
- use >800 ?g/day BDP or equal
- require three or extra courses of bronchial asthma treatment
Fundamental healthcare provision
The working occasion spent a while debating the minimal stage of effort that may impact the change. This example is more likely to come up in direction of the center of subsequent yr, when CFC-containing BDP inhalers change into more and more troublesome to acquire. With a purpose to keep away from a number of calls from group pharmacists in search of permission to provide options, practices might bulk change repeat prescriptions by laptop, and letters could possibly be despatched to sufferers informing them of the change. These letters ought to supply an invite to contact the GP or bronchial asthma nurse if there are any issues. This strategy has been utilized in some areas, however the guideline stresses that this technique ought to solely be used if unavoidable. Sufferers equivalent to these detailed in Field 1 can be significantly put in danger by this coverage.3
Kids are one other group who must be monitored rigorously through the changeover. Nevertheless, with just one CFC-free BDP preparation licensed for underneath 12 yr olds (i.e. Clenil Modulite®),5 there’s little alternative and a few drift in direction of dry powder gadgets might end result, significantly as Clenil Modulite® is required to be prescribed with a Volumatic® spacer.
Assessment of the bronchial asthma routine in kids is a chance to verify that dosages are inside really helpful limits, and to make sure that mother and father/carers and youngsters perceive the brand new dosage and know to not exceed it.
Implementing the change
If the changeover is deliberate and managed, it may be performed with help from native hospitals and group pharmacies. Right here within the North West, the newest NHS Buying and Provide Company contract incorporates particulars of different hydrofluoroalkane-containing inhalers, which means that hospitalised sufferers will quickly obtain a CFC-free inhaler. It can be crucial they proceed to make use of the identical gadget on discharge and that their previous one is faraway from their traditional repeat drugs. This can scale back the chance of a number of modifications. Group pharmacies must also learn of deliberate modifications in order that they’ll present well timed recommendation on the changeover, and in order that they could handle their shares appropriately.
All sufferers will most likely now be acquainted with CFC-free bronchodilators and the ‘warmer’, softer spray from their new BDP inhaler mustn’t come as a shock. Nevertheless, will probably be value reminding them that this transformation will not be for causes of security however from environmental issues, so their previous inhaler can be utilized up. Nevertheless, it can be crucial that these sufferers perceive any variations when beginning the brand new one.
The Medicines and Healthcare Merchandise Regulatory Company has already really helpful the prescribing of CFC-free BDP inhalers by model identify in view of the elevated efficiency of Qvar® in contrast with Clenil Modulite® and CFC-containing inhalers.6 Allotting pharmacists are suggested to verify with the prescriber if a CFC-free product is required however not named.6 The changeover to CFC-free salbutamol appeared to occur easily and, with no variations in doses, may have occurred within the pharmacy or the GP apply. Nevertheless, the change of steroid inhaler will not be more likely to be so easy as there’s a alternative of two, non-bioequivalent merchandise. Desk 1 lists potential different ICS inhalers
Desk 1: Potential different ICS inhalers for sufferers at present utilizing CFC-containing BDP inhalers3
Dose equivalence (HFA:CFC BDP gadget)
Licensed really helpful dosage for adults
Licensed for kids?
1:2 (i.e. dose is halved)
50–200 µg b.i.d., max 400 µg b.i.d. (i.e. 800 µg b.i.d. CFC-containing BDP equal)
Age ?12 years
200 µg b.i.d. (in additional extreme instances initially 600–800 µg day by day),
max 2000 µg day by day
50–100 µg 2–4 instances day by day
160 µg as soon as day by day, decreasing to 80 µg if management maintained
Age ?12 years
Age ?16 years: 100–250 µg b.i.d., max 1 mg
Age 4–16 years: 50–100 µg b.i.d., max 200 µg b.i.d.
(NB 125 µg and 250 µg usually are not indicated for kids)
Aside from AeroBec® and Beclazone Easi-Breathe®, all ICS breath-actuated pMDIs are CFC-free. A number of merchandise can be found.
DPIs don’t comprise propellants. A number of merchandise can be found.
*This isn’t an exhaustive checklist of steroids out there; †metered dose inhalers
ICS=inhaled corticosteroids; CFC=chlorofluorocarbon; BDP=beclometasone dipropionate; HFA=hydrofluoroalkane; b.i.d.=twice day by day; pMDI=pressurised metered-dose inhaler; DPI=dry powder inhaler
From October 2007, there was a rise within the value of CFC-containing BDP within the Drug Tariff,7 the place it has elevated by between 38% (50 ?g inhaler) and 92% (250 ?g inhaler). This now makes it dearer than equal CFC-free pMDIs and, subsequently, on purely prescribing value grounds, a change to CFC-free inhalers sooner slightly than later may truly scale back prices. Prices of chosen ICS pMDIs and BAIs are proven in Desk 2.
Desk 2: Prices of chosen ICS pMDIs and BAIs8
Price per unit* (£)
Variety of doses
Qvar Autohaler® BAI
Qvar Easi-Breathe® pMDI
Flixotide Evohaler® BAI
*Costs appropriate as of 1 December 2007 and topic to vary; †Qvar® is prescribed at half the dose
ICS=inhaled corticosteroids; pMDI=pressurised metered-dose inhaler; BAI=breath-actuated inhaler
In abstract, the consensus guideline advises that the change must be deliberate now, to permit for selections concerning the CFC-free BDP options to be made, with particular issues making use of for every of the 2 choices (Clenil Modulite® or Qvar®). If deliberate and managed over a time frame, the change needn’t create vital extra workload for prescribers and dispensers.
Follow-based commissioning take-home messages
written by Dr David Jenner, NHS Alliance PBC Lead
- At the moment, CFC-free BDP inhalers are cheaper than previous generic CFC-containing BDP inhalers, so it’s time to change now
- Generic CFC-containing BDP 100 µg inhaler = £9.65a
- Clenil Modulite® 100 µg = £7.72b
- Qvar® 50 µg (dose equal) = £7.87a
- Clenil Modulite® is the one CFC-free BDP preparation licensed to be used in sufferers underneath 12 years of age
- The change is ideally achieved at a face-to-face bronchial asthma overview, which features a overview of present remedy
- The change from CFC-based inhalers may save prescribing prices if remedy will be stepped down
- Bronchial asthma opinions appeal to remuneration from the QOF
- Group pharmacists are nicely positioned to tell sufferers concerning the change with a medication use overview. Plan the change with them!
CFC=chlorofluorocarbon; BDP=beclometasone dipropionate; QOF=high quality and outcomes framework
bBritish Nationwide Formulary September 2007. London: BMJ Publishing Group Ltd, Royal Pharmaceutical Society, 2007